Understanding oral feeding and disorders in extremely preterm infants
Analysis of the Factors Influencing the Acquisition of Full Oral Feeding in Very Preterm Infants
This study looks at how oral feeding problems affect extremely premature infants and aims to find ways to help them feed better and develop their oral skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | N/A to 28 Weeks |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06648083 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on extremely premature infants born before 29 weeks of gestation, who often experience oral disorders that can hinder their ability to feed orally. The study aims to gather data on the incidence of these oral disorders and their impact on the infants' development, particularly in acquiring full oral feeding and developing oral skills. By analyzing the effects of less aggressive care and parental involvement, the research seeks to provide insights into improving care practices for these vulnerable infants. The study will include infants admitted to the neonatology department within the first three days of life and discharged directly to home.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at a gestational age of 28 weeks or less who were admitted to the neonatology department shortly after birth.
Not a fit: Patients who may not benefit from this study include those with severe pathologies requiring surgical management or significant malformations.
Why it matters
Potential benefit: If successful, this study could lead to improved feeding practices and developmental outcomes for extremely preterm infants.
How similar studies have performed: While there is limited data on the specific incidence of oral disorders in extremely preterm infants, previous studies have indicated that less aggressive care and parental involvement can positively influence developmental outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born at a gestational age ≤ 28 weeks * Born between January 1, 2018 and December 31, 2021 * Admitted in the first three days of life in the neonatology department of the Croix-Rousse hospital * Discharged directly to home (or to a nursery) Exclusion Criteria: * Infants re-transferred to another department during hospitalization * Infants with a severe pathology requiring surgical management in the first weeks of life. Inguinal hernia repair is not concerned * Severe malformation * Refusal of the parents
Where this trial is running
Lyon
- Hopital Croix Rousse — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Pr PICAUD Jean-Charles, MD, PhD
- Email: jean-charles.picaud@chu-lyon.fr
- Phone: +33472004121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.